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Remote Contractor, Medical Writer en Generate:biomedicines

Generate:biomedicines ·  Remote, US, Estados Unidos De América · Remote

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About Generate Biomedicines

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received over $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role:

This is 6 month Remote contractor role; 15-20 hours a week, paying $70-75 per hour.

We are seeking a highly skilled Contractor, Medical Writer with strong experience in regulatory writing. The ideal candidate will have a strong background in nonclinical and clinical regulatory writing, including the development of critical regulatory documents such as clinical protocols, Investigator’s Brochures, nonclinical overviews and written summaries, clinical study reports, and nonclinical study reports. This is a remote contract role requiring strong scientific writing expertise and the ability to contribute effectively in a fast-paced environment. 

Here's how you will contribute:

  • Develop and author high-quality regulatory and scientific documents, including but not limited to:
    • Clinical Protocols
    • Investigator’s Brochures (IBs)
    • Nonclinical Overviews and Written Summaries
    • Nonclinical Study Reports
    • Clinical Study Reports (CSRs)
  • Collaborate cross-functionally with regulatory, clinical, and nonclinical teams to ensure accuracy and alignment of scientific and regulatory content.
  • Interpret complex scientific data and present it in a clear, concise, and regulatory-compliant manner.
  • Ensure adherence to regulatory guidelines (ICH, FDA, EMA, etc.), company standards, and industry best practices.
  • Support regulatory submission activities by preparing high-quality documents in compliance with electronic submission requirements.

The Ideal Candidate will have: 

  • Minimum 10 years of experience in the biotechnology or pharmaceutical industry.
  • At least 8 years of experience in medical writing with a strong emphasis on regulatory writing.
  • Extensive experience with nonclinical writing, including contributions to nonclinical study reports and nonclinical regulatory documentation.
  • Advanced degree in life sciences (PhD, PharmD, or MS) preferred;
  • Strong knowledge of ICH guidelines and regulatory requirements for global regulatory submissions.
  • Excellent writing, editing, and analytical skills with a proven ability to translate complex scientific data into well-structured, regulatory-compliant documents.
  • Ability to work independently, manage multiple projects, and meet tight deadlines in a fast-paced environment.
  • Experience with document management systems (e.g., Veeva, eCTD submissions) is a plus.

Location: Remote; travel to Somerville, MA office as business dictates.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

COVID Safety:

Generate:Biomedicines enforces a mandatory vaccination policy for COVID-19. All employees must be fully vaccinated and have received a booster.  The purpose of this policy is to safeguard the health of our employees, their families, and the community at large from infectious disease that may be reduced by vaccinations.  The Company will make exceptions to this policy if required by applicable law and will consider requests for an exemption from this policy due to a medical reason, or because of a sincerely held religious belief, or any other exemptions that may be recognized by applicable.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

 

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